Egyptian Ancestry  Design  Objective –SVR 12 (HCV RNA < 25 IU/ml), with 95% CI SOF 400 mg qd + RBV Randomised 1 : 1 Open-label Egyptian Ancestry Study:

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Presentation transcript:

Egyptian Ancestry  Design  Objective –SVR 12 (HCV RNA < 25 IU/ml), with 95% CI SOF 400 mg qd + RBV Randomised 1 : 1 Open-label Egyptian Ancestry Study: SOF + RBV for HCV genotype 4 W12 ≥ 18 years 1 st generation egyptian Chronic HCV infection, genotype 4 HCV RNA ≥ 10,000 IU/ml Treatment-naïve or experienced Cirrhosis* allowed No HBV or HIV co-infection * by liver biopsy, or Fibrotest ® ≥ APRI > 2 N = 29 N = 31 W24 RBV : 1000 or 1200 mg/day (bid dosing) according to body weight (< or ≥ 75 kg) Ruane P. J. Hepatology 2015;62:1040-6

SOF + RBV 12 weeks N = 31 SOF + RBV 24 weeks N = 29 Mean age, years5355 Female29%34% HCV RNA, log 10 IU/ml, mean6.0 IL28B CC genotype13%21% Cirrhosis23%24% Treatment naïve45%48% Treatment experienced55%52% Past treatment category Relapse Non response Other (intolerance, unknown response) 29% 59% 12% 7% 67% 26% Completed treatment3129 Completed W12 of follow-up post-treatment2228 Baseline characteristics and patient disposition Egyptian Ancestry Egyptian Ancestry Study: SOF + RBV for HCV genotype 4 Ruane P. J. Hepatology 2015;62:1040-6

SVR 12 (HCV RNA < 25 IU/ml) All n NaïveExpe- rienced CCNon CC < 800K≥ 800KNoYesAllNaïveExpe- rienced CCNon CC < 800K≥ 800KNoYes Egyptian Ancestry Egyptian Ancestry Study: SOF + RBV for HCV genotype 4 Ruane P. J. Hepatology 2015;62: % Baseline HCV RNA, IU/ml IL28BCirrhosisBaseline HCV RNA, IU/ml IL28BCirrhosis SOF + RBV 12WSOF + RBV 24W

Adverse events, N (%) SOF + RBV 12W, N = 31SOF + RBV 24W, N = 29 Adverse event leading to discontinuation00 Serious adverse event03 AE in ≥ 20 % of patients Headache Insomnia Fatigue Cough Irritability Dizziness Pruritus Oropharyngeal pain Dyspnea Abdominal distension Pain Rash Myalgia Nausea Palpitations Diarrhea 58% 52% 45% 19% 16% 23% 16% 13% 3% 6% 3% 66% 48% 52% 45% 34% 31% 24% 28% 24% 21% 31% 21% Egyptian Ancestry Egyptian Ancestry Study: SOF + RBV for HCV genotype 4 Ruane P. J. Hepatology 2015; 62:1040-6

 Summary –In this phase II, open-label study, 24 weeks of treatment with SOF and RBV resulted in high rates of SVR 12 in treatment-naive and previously treated patients with genotype 4 HCV infection. SVR 12 rates were notably high in patients with characteristics historically associated with poor response : cirrhosis, high baseline viral load, non-CC IL28B genotype, and prior non-response to HCV treatment –Limitations Small sample size Small number (12 = 20%) of patients infected with non-4a HCV Egyptian Ancestry Egyptian Ancestry Study: SOF + RBV for HCV genotype 4 Ruane P. J. Hepatology 2015;62:1040-6